Director, Precision Medicine and IVD Development

Precede Biosciences, Inc.; Cambridge (MA); On-site; USD 200,000 - 250,000; Full time

Benefits offered by this job

Performance bonuses

Equity participation

Comprehensive health benefits

Job summary

Precede Biosciences, Inc. is seeking an experienced strategic product leader to own the IVD product strategy for companion diagnostics and LDT products.

You will guide development through cross-functional collaboration with R&D, Translational Science, and Biopharma to translate clinical needs into robust product specifications and validation plans. The role demands deep expertise in NGS-based diagnostics, cfDNA biology, and regulatory pathways, with a track record of leading CDx partnerships and

Qualifications

• 10+ years of experience developing NGS-based IVDs, with at least 5 years in molecular diagnostics, oncology diagnostics, or precision medicine.
• Direct experience developing and launching diagnostic products through both LDT and companion diagnostic pathways.
• Experience collaborating with biopharma and academic partners to develop novel biomarkers and diagnostic solutions.

Responsibilities

• Develop and own IVD product strategy across companion diagnostics and LDT products and programs.
• Define clinical reporting strategy of biomarkers and the validation evidence required to enable clinical reporting.
• Lead the maturation and improvement of the IVD product development function with processes, frameworks, and best practices.
• Partner with R&D, Translational Science and Biopharma to translate customer needs into product specifications and acceptance criteria.

Skills

Strategic thinking

Cross-functional leadership

Communication skills

Data-driven decision making

Stakeholder management

Entrepreneurial mindset

Education

Advanced degree (PhD or MD) in life sciences

Job description

About Us

We are pioneering an advanced, minimally invasive, comprehensive epigenomics platform with the potential to profoundly impact the research and development of new medicines and the use of approved medicines in clinical practice across a number of conditions, including cancer. More information on our company and platform can be found on our company website.

We care deeply about creating a place where folks can do their best work from the start and have intentionally created an environment that is defined by purpose, teamwork, and excellence. This means nurturing team spirit, facing challenges together, collaboratively solving complex problems, while also ensuring a strong focus on individual initiative, accountability, and delivery.

What You'll Do

Strategic Product Leadership

• Develop and own IVD product strategy across companion diagnostics and LDT products and programs, by identifying opportunities strategically aligned with company objectives, market opportunities, and the competitive landscape
• Define clinical reporting strategy of Precede Bioscience’s novel biomarkers and the validation evidence required to enable clinical reporting
• Lead and continue the maturation and improvement of the IVD product development function, defining processes, frameworks, and best practices appropriate for our stage and growth trajectory

Cross-Functional Product Development

• Partner with R&D, Translational Science and Biopharma to translate and integrate customer needs and clinical requirements into product specifications and acceptance criteria
• Partner with the Computational Biology and Product Development teams to design validation and utility studies that support product claims and reimbursement
• Collaborate with regulatory affairs to define regulatory strategy (LDT vs. FDA submission pathway) for each product

Companion Diagnostic Partnerships

• Serve as product lead for CDx pharma partnerships, understanding drug development timelines and CDx biomarker requirements
• Define product requirements for companion diagnostics aligned with partner therapeutic programs
• Manage product-related aspects of collaboration agreements, including deliverables, milestones, and success metrics

Market & Customer Insights

• Conduct voice-of-customer research with oncologists, pathologists, pharmaceutical partners, and research customers to identify unmet needs and validate product concepts
• Analyze competitive landscape in cfDNA diagnostics, monitoring developments from other pioneering diagnostic companies
• Synthesize market intelligence, reimbursement trends, and clinical evidence requirements to inform product strategy
• Build relationships with key opinion leaders and clinical collaborators to guide product development

Experience

Who You Are

• A minimum of 10 years of experience developing NGS-based IVDs, with at least 5 years in molecular diagnostics, oncology diagnostics, or precision medicine
• Direct experience developing and launching diagnostic products through both LDT and companion diagnostic pathways
• Experience collaborating with biopharma and academic partners to develop novel biomarkers and diagnostic solutions

Technical & Domain Knowledge

• Deep understanding of cancer biology, cfDNA biology, liquid biopsy technologies, and NGS-based diagnostic workflows
• Knowledge of oncology diagnostic landscape, including competitive products, clinical utility requirements, and adoption barriers
• Understanding of regulatory pathways (CLIA/CAP for LDTs, FDA approval/clearance for IVDs, companion diagnostic regulations)
• Familiarity with reimbursement landscape for molecular diagnostics, including Medicare LCD/LCA processes and private payer coverage

Skills & Competencies

• Strong strategic thinking with ability to balance long-term vision with near-term execution
• Excellent cross-functional leadership and influence without authority
• Outstanding communication skills with ability to present to diverse audiences, from technical teams to executive leadership
• Data-driven decision making with proficiency in analyzing market data, customer research, and product metrics
• Experience managing complex stakeholder relationships including pharma partners, clinicians, and internal teams
• Entrepreneurial mindset with comfort operating in ambiguity and resource-constrained environments

Education & Preferred Qualifications

• Advanced degree PhD and/or MD in life sciences, molecular biology, oncology, pathology or related field
• Direct experience with cfDNA/ctDNA assays and liquid biopsy applications in oncology
• Experience with both US and international IVD products

The expected salary range for this role is $200,000 - $250,000 per year. Final compensation will be based on a candidate’s qualifications, experience, and geographic location.

• Employees are also eligible for performance bonuses, equity participation and comprehensive health benefits.

We believe in building an inclusive and balanced team. We also know meeting every single-exact-criteria can get in the way of meeting stellar folks.

Precede Biosciences is an equal opportunity employer. We do not discriminate in regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, ancestry, physical or mental disability, veteran status, or any other legally protected.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.